GXP QC IT Application Analyst – Onsite Validation Upgrades

Lancesoft; Lexington (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Lancesoft seeks a QC IT Application Analyst to collaborate with business and IT teams, supporting GMP operations and validation activities. The role involves overseeing SDLC documentation, user access reviews, and audit trails, while managing multiple projects with limited supervision.

Ideal candidates have 5+ years in IT/business within a regulated environment, a relevant degree, and experience with tools like ServiceNow, TrackWise, and Veeva.

Qualifications

• More than 5 years relevant IT/business experience in GxP environment is required.
• Bachelor's degree or equivalent in IT/science/engineering or business administration is required.
• Experience in Pharmaceuticals or Life Sciences is preferred.

Responsibilities

• Provide project support for MA Biologics Operations Site Functions Quality, Validation and Product Development.
• Manage work with limited oversight; upgrade projects from Windows 7 to Windows 10.
• Handle ad-hoc technical requests from internal and external partners.

Skills

IT experience

SDLC documentation

GxP knowledge

Active Directory

NTFS permissions

SQL databases

LDAP

Windows Server

Citrix

Veeva

TrackWise

ServiceNow

21 CFR 11

Education

Bachelor's degree in IT/CS/Engineering

Tools

ServiceNow

TrackWise

Veeva

Citrix

MS Office

Job description

Lancesoft seeks a QC IT Application Analyst to collaborate with business and IT teams, supporting GMP operations and validation activities. The role involves overseeing SDLC documentation, user access reviews, and audit trails, while managing multiple projects with limited supervision.

Ideal candidates have 5+ years in IT/business within a regulated environment, a relevant degree, and experience with tools like ServiceNow, TrackWise, and Veeva.